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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

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CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 20027E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
The customer reported a leak at the filter.No patient harm was reported.
 
Event Description
The customer reported a leak occurred at an unknown location during an infusion.No patient harm was reported.
 
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Brand Name
ALARIS EXTENSION SET
Type of Device
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8289296
MDR Text Key134495615
Report Number9616066-2019-00161
Device Sequence Number1
Product Code FPB
UDI-Device Identifier10885403234859
UDI-Public10885403234859
Combination Product (y/n)N
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/18/2021
Device Model Number20027E
Device Catalogue Number20027E
Device Lot Number18096146
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRI TUBING, THERAPY DATE UNK; PRI TUBING, THERAPY DATE UNK
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